Atofit

Atofit

atorvastatin

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Atorvastatin
Indications/Uses
Adjunct to diet for the reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B & triglycerides in patients w/ primary hypercholesterolemia, combined or mixed hyperlipidemia, heterozygous & homozygous familial hypercholesterolemia when diet response & non-pharmacological measures are inadequate. Hypertensive patient (≥40 yr) & dyslipidemia w/ at least 3 risk factors for future CV events eg, LVH, ECG abnormalities, NIDDM, peripheral vascular disease, past history of cerebrovascular events including previous TIA ≥3 mth, microalbuminuria/proteinuria, smoking (regular smoker w/in the last yr of 20 cigarettes or cigars/wk), TC/HDL-C ratio ≥6 & history of CAD event in 1st degree relative before age 55 (males) or 60 (females). Reduce the risk of fatal CHD, non-fatal MI, stroke, revascularization procedures & angina pectoris. Adjunct to diet to reduce total-C, LDL-C & apo B levels in boys & postmenarchal girls 10-17 yr w/ heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following are present: LDL-C remains ≥190 mg/dL, or LDL-C remains ≥160 mg/dL & positive family history of premature CV disease or ≥2 CV disease risk factors are present.
Dosage/Direction for Use
Individualized starting & maintenance dosage according to baseline LDL-C levels, goal therapy & patient response. Usual starting dose: 10 mg once daily. Dose range: 10-80 mg once daily. Primary hypercholesterolemia & combined (mixed) hyperlipidemia 10 mg once daily. Homozygous familial hypercholesterolemia 80 mg daily. Heterozygous familial hypercholesterolemia Ped patient (10-17 yr) Initially 10 mg daily. Max: 20 mg daily. Dose adjustment should be made at intervals of ≥4 wk. Childn Max: 80 mg daily. Co-administration w/ cyclosporine Max: 10 mg.
Administration
May be taken with or without food: Avoid excessive consumption (>1 L/day) of grapefruit juice.
Contraindications
Hypersensitivity. Active liver disease or unexplained persistent elevation of serum transaminases >3 times the upper limit of normal. Women who are pregnant, breastfeeding or of childbearing potential who are not using adequate contraceptive measures.
Special Precautions
Perform liver function test prior to the initiation of treatment, at 12 wk following both initiation & any evaluation of dose, & periodically (semiannually) thereafter; & in patients who develop liver injury. Monitor patients who develop increased transaminase levels until abnormalities resolved. Reduce dose or w/draw if increase in ALT or AST is >3 times the upper limit of normal persist. Elevated transaminases & creatine phosphokinase. Patients who consume substantial quantities of alcohol &/or have a history of liver disease. Myalgia. Discontinue treatment if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Carefully monitor patients for any signs & symptoms of muscle pain, tenderness or weakness in combined therapy w/ fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals or niacin; skeletal muscle effects. Temporarily discontinue use during fusidic acid therapy; in patients w/ acute, serious condition suggestive of a myopathy or risk factor predisposing to development of renal failure secondary to rhabdomyolysis. Hemorrhagic stroke. Promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Increased HbA1c & fasting serum glucose. Prior to initiating therapy an attempt to control hypercholesterolemia w/ appropriate diet, exercise & wt reduction in obese patients, & to treat underlying medical problems should be made. Adolescent females & women of childbearing potential should use adequate contraceptive measures. Discontinue therapy if the patient becomes pregnant.
Adverse Reactions
Insomnia; headache, peripheral neuropathy, paraesthesia; GI disorders; myalgia, arthralgia; myopathy, myositis, muscle cramps, rhabdomyolysis, back pain; asthenia, angioneurotic edema, malaise, chest pain, peripheral edema, fatigue; hypoglycemia, hyperglycemia, anorexia; tinnitus; hepatitis, cholestatic jaundice; alopecia, pruritus, rash, urticaria; impotence; angina. Nasopharyngitis; pharyngolaryngeal pain, epistaxis.
Drug Interactions
Increased risk of myopathy w/ concurrent administration of cyclosporine, fibric acid derivatives, niacin or CYP450 3A4 inhibitors eg, erythromycin & azole antifungals. Increased plasma conc w/ CYP450 3A4 inhibitors (eg, erythromycin & clarithromycin, PIs), diltiazem, itraconazole & grapefruit juice. Increased bioavailability w/ OATP1B1 inhibitors eg, cyclosporine. Reduced plasma conc w/ CYP450 3A4 inducers (eg, efavirenz, rifampin), antacid containing Mg- & Al hydroxide & colestipol. Increased conc of digoxin. Increased AUC of OCs containing norethindrone & ethinyl estradiol. Severe muscle problems eg, rhabdomyolysis w/ fusidic acid. Ketoconazole, spironolactone & cimetidine.
ATC Classification
C10AA05 - atorvastatin ; Belongs to the class of HMG CoA reductase inhibitors. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Atofit FC tab 40 mg
Packing/Price
3 × 10's
Form
Atofit FC tab 20 mg
Packing/Price
3 × 10's
Form
Atofit FC tab 10 mg
Packing/Price
3 × 10's
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